WASHINGTON, Feb. 12, 2013 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical
company focused on the development and commercialization of
products for the treatment of central nervous system disorders,
today announced financial and operational results for the fourth
quarter and full year ended December 31,
2012.
Key Highlights:
- Vanda reported positive SET and RESET Phase III efficacy
studies for tasimelteon in the treatment of patients with
Non-24-Hour Disorder (Non-24). Study results demonstrate
tasimelteon is a unique circadian regulator that resets the master
body clock and improves clinical symptoms in patients with
Non-24.
- The tasimelteon Non-24 program continues towards the goal of
a projected mid-2013 New Drug Application (NDA) filing with the
U.S. Food and Drug Administration (FDA).
- All tasimelteon activities have been discontinued related to
the Major Depressive Disorder (MDD) indication. In
January 2013, Vanda announced that
the MAGELLAN Phase IIb/III clinical study did not meet its primary
endpoint.
- Vanda has formally requested a re-examination of the
negative opinion issued by the European Medicines Agency (EMA)
recommending against approval of Fanaptum™
(oral iloperidone tablets) in the European Union.
- Vanda recorded full year 2012 revenue of $32.7 million including Fanapt® royalties of
$5.9 million. Fanapt®
prescriptions, as reported by IMS, were approximately 38,200 for
the fourth quarter of 2012. This represents a 1% decrease
versus third quarter 2012 prescriptions and a 13% increase over
fourth quarter 2011 prescriptions.
FULL YEAR 2012 REPORTED RESULTS
Total revenues for the full year 2012 were $32.7 million, compared to $31.3 million for 2011. Full year 2012
revenues included $5.9 million in
Fanapt® royalties received from Novartis, as compared to
$4.5 million for the prior year.
Both 2012 and 2011 revenues include $26.8 million recognized from the $200.0 million upfront payment previously
received from Novartis for Fanapt® U.S. and Canadian
rights.
Total operating expenses for 2012 were $61.0 million, compared to $42.0 million for 2011. The primary driver
of the higher expenses in 2012 was the ongoing support of the
tasimelteon Non-24 and MDD clinical studies.
Vanda recorded a net loss of $27.7
million for 2012, compared to net loss of $9.8 million for 2011. Diluted net loss per
share for 2012 was $0.98, compared to
a diluted net loss per share of $0.35
for 2011.
Vanda's cash, cash equivalents and marketable securities as of
December 31, 2012 totaled
$120.4 million.
FOURTH QUARTER 2012 REPORTED RESULTS
Total revenues for the fourth quarter of 2012 were $7.9 million, compared to $8.4 million for 2011. Fourth quarter 2012
revenues included $1.2 million in
Fanapt® royalties received from Novartis as compared to
royalties of $1.6 million for the
fourth quarter of 2011.
Total operating expenses for the fourth quarter of 2012 and 2011
were each $14.3 million.
Vanda recorded a net loss of $6.4
million for the fourth quarter of 2012, compared to a net
loss of $5.5 million for the fourth
quarter of 2011. Diluted net loss per share for the fourth
quarter of 2012 was $0.23, compared
to a diluted net loss of $0.20 per
share for the fourth quarter of 2011.
Full
Year December 31, 2012 Key Financial
Figures1
|
|
|
|
|
|
|
|
|
|
Twelve
Months Ended
|
|
|
|
|
|
December 31
|
|
December 31
|
|
|
|
|
(in
thousands, except per share amounts)
|
2012
|
|
2011
|
|
Change ($)
|
|
Change
(%)
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
32,727
|
|
$
31,270
|
|
$
1,457
|
|
5%
|
Research
& development expenses
|
45,446
|
|
28,996
|
|
16,450
|
|
57%
|
General
& administrative expenses
|
13,882
|
|
11,486
|
|
2,396
|
|
21%
|
Non-cash
stock-based compensation2
|
4,094
|
|
5,501
|
|
(1,407)
|
|
(26%)
|
Loss
before tax benefit
|
(27,664)
|
|
(10,246)
|
|
(17,418)
|
|
(170%)
|
Tax
benefit
|
-
|
|
(444)
|
|
444
|
|
100%
|
Net
loss
|
(27,664)
|
|
(9,802)
|
|
(17,862)
|
|
(182%)
|
|
|
|
|
|
|
|
|
Diluted
net loss per share
|
$
(0.98)
|
|
$
(0.35)
|
|
$
(0.63)
|
|
(180%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth
Quarter 2012 Key Financial Figures1
|
|
|
|
|
|
|
|
|
|
Three
Months Ended
|
|
|
|
|
|
December 31
|
|
September 30
|
|
|
|
|
(in
thousands, except per share amounts)
|
2012
|
|
2012
|
|
Change ($)
|
|
Change
(%)
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
7,920
|
|
$
8,288
|
|
$
(368)
|
|
(4%)
|
Research
& development expenses
|
10,617
|
|
10,159
|
|
458
|
|
5%
|
General
& administrative expenses
|
3,225
|
|
3,147
|
|
78
|
|
2%
|
Non-cash
stock-based compensation2
|
923
|
|
576
|
|
347
|
|
60%
|
Loss
before tax benefit
|
(6,369)
|
|
(5,326)
|
|
(1,043)
|
|
(20%)
|
Tax
benefit
|
-
|
|
-
|
|
-
|
|
|
Net
loss
|
(6,369)
|
|
(5,326)
|
|
(1,043)
|
|
(20%)
|
|
|
|
|
|
|
|
|
Diluted
net loss per share
|
$
(0.23)
|
|
$
(0.19)
|
|
$
(0.04)
|
|
(21%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Select
Cash Flow Data1
|
|
|
|
|
|
Twelve
Months Ended
|
|
December 31
|
|
December 31
|
(in
thousands)
|
2012
|
|
2011
|
Net cash
provided by (used in)
|
|
|
|
Operating
activities
|
$
(44,917)
|
|
$
(28,410)
|
Investing
activities
|
45,754
|
|
73,749
|
Financing
activities
|
12
|
|
25
|
|
|
|
|
|
|
|
|
Select
Balance Sheet Data1
|
|
|
|
|
|
|
|
December 31
|
|
September 30
|
|
December 31
|
(in
thousands)
|
2012
|
|
2012
|
|
2011
|
|
|
|
|
|
|
Total cash
and marketable securities
|
$
120,403
|
|
$
134,404
|
|
$
167,896
|
|
|
|
|
|
|
(1)
Unaudited
|
(2)
Non-cash stock-based compensation is allocated to both Research
& development and General & administrative
expenses
|
OPERATIONAL HIGHLIGHTS
In December 2012 and January 2013, Vanda announced positive results
for two Phase III studies for tasimelteon in the treatment of
Non-24. The SET Phase III study demonstrated that tasimelteon
was able to entrain the master body clock as measured by melatonin
and cortisol circadian rhythms. Tasimelteon was also shown to
significantly improve clinical symptoms across a number of sleep
and wake measures. These results provided robust evidence of
direct and clinically meaningful benefits to patients with
Non-24. The RESET Phase III study demonstrated the
maintenance effect of 20mg of tasimelteon to entrain melatonin and
cortisol circadian rhythms in individuals with Non-24.
Patients treated with tasimelteon maintained their clinical
benefits while patients receiving placebo showed significant
deterioration in measures of nighttime sleep, daytime naps and
timing of sleep. Non-24 is a serious, rare circadian rhythm
disorder that affects a majority of totally blind individuals who
lack light perception and cannot entrain (reset) their master body
clock to the 24-hour day. Currently there is no approved
treatment for Non-24.
Vanda plans to submit an NDA to the FDA in mid-2013. Vanda
will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on
tasimelteon in the treatment of patients with Non-24.
Vanda has decided to discontinue all activities related to the
MDD indication. In January, Vanda announced that the MAGELLAN
Phase IIb/III clinical study in MDD did not meet the primary
endpoint of a change from baseline in the Hamilton Depression Scale
(HAMD-17) after 8 weeks of treatment as compared to
placebo.
Vanda has formally appealed the EMA's negative opinion for
Fanaptum™ (oral iloperidone tablets) and requested a
re-examination of the decision by the EMA's Committee for Medicinal
Product for Human Use (CHMP). In December 2012, the CHMP issued a negative opinion
recommending against approval of Fanaptum™ for the
treatment of schizophrenia in adult patients in the European
Union.
Vanda recorded full year 2012 revenue of $32.7 million including Fanapt®
royalties of $5.9 million.
Fanapt® prescriptions, as reported by IMS, were
approximately 38,200 for the fourth quarter of 2012. This
represents a 1% decrease versus third quarter 2012 prescriptions
and a 13% increase over fourth quarter 2011
prescriptions.
CONFERENCE CALL
Vanda has scheduled a conference call for today, Tuesday, February 12, 2013, at 10:00 AM ET. During the call, Vanda's
management will discuss the fourth quarter and full year 2012
results and other corporate activities. Investors can call
800-901-5248 (domestic) and 617-786-4512 (international) and use
passcode 86594010. A replay of the call will be available
beginning Tuesday, February 12, 2013
at 12:00 PM ET and will be accessible
until Tuesday, February 19, 2013, at
5:00 PM ET. The replay call-in
number is 1-888-286-8010 for domestic callers and 1-617-801-6888
for international callers. The access number is 89804635.
The conference call will be broadcast simultaneously on Vanda's
website, http://www.vandapharma.com. Investors should click
on the Investor Relations tab and are advised to go to the website
at least 15 minutes early to register, download, and install any
necessary software or presentations. The call will also be
archived on Vanda's website for a period of 30 days, through
March 14, 2013.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of products for
the treatment of central nervous system disorders. For more
on Vanda, please visit http://www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release are "forward-looking
statements" under the securities laws. Words such as, but not
limited to, "believe," "expect," "anticipate," "estimate,"
"intend," "plan," "project," "target," "goal," "likely," "will,"
"would," and "could," or the negative of these terms and similar
expressions or words, identify forward-looking statements.
Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and
uncertainties. Important factors that could cause actual results to
differ materially from those reflected in the company's
forward-looking statements include, among others: the inability to
reach agreement with the FDA regarding Vanda's regulatory approval
strategy or proposed path to approval for tasimelteon for the
treatment of Non-24; Vanda's failure to obtain regulatory approval
for tasimelteon for the treatment of Non-24 or to comply with
ongoing regulatory requirements; the extent and effectiveness of
the development, sales and marketing and distribution support
Fanapt® receives; Vanda's ability to successfully
commercialize Fanapt® outside of the U.S. and
Canada and other factors that are
described in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections
of Vanda's annual report on Form 10-K for the fiscal year ended
December 31, 2011 which is on file
with the SEC and available on the SEC's website at
www.sec.gov. In addition to the risks described above and in
Vanda's annual report on Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K and other filings with the SEC, other
unknown or unpredictable factors also could affect Vanda's results.
There can be no assurance that the actual results or developments
anticipated by Vanda will be realized or, even if substantially
realized, that they will have the expected consequences to, or
effects on, Vanda. Therefore, no assurance can be given that the
outcomes stated in such forward-looking statements and estimates
will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is provided
only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended
|
|
Twelve
Months Ended
|
(in
thousands, except for share)
|
December
31
|
|
December
31
|
|
December
31
|
|
December
31
|
and per
share amounts)
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
agreement
|
|
$
|
6,752
|
|
$
|
6,752
|
|
$
|
26,789
|
|
$
|
26,789
|
|
Royalty
revenue
|
|
|
1,168
|
|
|
1,618
|
|
|
5,938
|
|
|
4,481
|
|
|
Total
revenues
|
|
|
7,920
|
|
|
8,370
|
|
|
32,727
|
|
|
31,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
129
|
|
|
-
|
|
|
129
|
|
|
-
|
|
Research
and development
|
|
10,617
|
|
|
10,556
|
|
|
45,446
|
|
|
28,996
|
|
General
and administrative
|
|
3,225
|
|
|
3,345
|
|
|
13,882
|
|
|
11,486
|
|
Intangible
asset amortization
|
|
377
|
|
|
377
|
|
|
1,495
|
|
|
1,495
|
|
|
Total
operating expenses
|
|
14,348
|
|
|
14,278
|
|
|
60,952
|
|
|
41,977
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(6,428)
|
|
|
(5,908)
|
|
|
(28,225)
|
|
|
(10,707)
|
|
Other
income
|
|
|
59
|
|
|
99
|
|
|
561
|
|
|
461
|
Loss
before tax benefit
|
|
|
(6,369)
|
|
|
(5,809)
|
|
|
(27,664)
|
|
|
(10,246)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
benefit
|
|
|
|
-
|
|
|
(286)
|
|
|
-
|
|
|
(444)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
$
|
(6,369)
|
|
$
|
(5,523)
|
|
$
|
(27,664)
|
|
$
|
(9,802)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
(0.23)
|
|
$
|
(0.20)
|
|
$
|
(0.98)
|
|
$
|
(0.35)
|
|
Diluted
|
|
|
$
|
(0.23)
|
|
$
|
(0.20)
|
|
$
|
(0.98)
|
|
$
|
(0.35)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in calculation of net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
28,233,409
|
|
|
28,115,175
|
|
|
28,228,409
|
|
|
28,106,831
|
|
Diluted
|
|
|
|
28,233,409
|
|
|
28,115,175
|
|
|
28,228,409
|
|
|
28,106,831
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
December
31, 2012
|
|
December
31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
|
$
|
88,772
|
|
$
|
87,923
|
|
|
Marketable
securities, current
|
|
|
31,631
|
|
|
60,961
|
|
|
Accounts
receivable
|
|
|
|
|
1,168
|
|
|
1,618
|
|
|
Inventory
|
|
|
|
|
|
57
|
|
|
-
|
|
|
Prepaid
expenses and other current assets
|
|
|
3,910
|
|
|
2,999
|
|
|
Restricted
cash, current
|
|
|
|
|
430
|
|
|
-
|
|
|
|
Total
current assets
|
|
|
|
|
125,968
|
|
|
153,501
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable
securities, non-current
|
|
|
-
|
|
|
19,012
|
|
Property
and equipment, net
|
|
|
|
2,348
|
|
|
964
|
|
Other
assets, non-current
|
|
|
|
|
-
|
|
|
84
|
|
Intangible
asset, net
|
|
|
|
|
6,532
|
|
|
8,027
|
|
Restricted
cash, non-current
|
|
|
|
600
|
|
|
1,030
|
|
|
|
Total
assets
|
|
|
|
$
|
135,448
|
|
$
|
182,618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
|
287
|
|
$
|
996
|
|
|
Accrued
liabilities
|
|
|
|
|
5,187
|
|
|
3,381
|
|
|
Deferred
rent, current
|
|
|
|
|
-
|
|
|
453
|
|
|
Deferred
revenues, current
|
|
|
|
26,789
|
|
|
26,789
|
|
|
|
Total
current liabilities
|
|
|
|
32,263
|
|
|
31,619
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
|
|
|
|
Deferred
rent, non-current
|
|
|
|
3,005
|
|
|
461
|
|
|
Deferred
revenues, non-current
|
|
|
90,275
|
|
|
117,064
|
|
|
|
Total
liabilities
|
|
|
|
|
125,543
|
|
|
149,144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
28
|
|
|
28
|
|
|
Additional
paid-in capital
|
|
|
|
|
300,974
|
|
|
296,868
|
|
|
Accumulated other comprehensive income
|
|
|
10
|
|
|
21
|
|
|
Accumulated deficit
|
|
|
|
|
(291,107)
|
|
|
(263,443)
|
|
|
|
Total
stockholders' equity
|
|
|
|
9,905
|
|
|
33,474
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$
|
135,448
|
|
$
|
182,618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPANY CONTACT:
Cristina Murphy
Senior Communications Manager
Vanda Pharmaceuticals Inc.
(202) 734-3414
cristina.murphy@vandapharma.com
SOURCE Vanda Pharmaceuticals Inc.